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NotablePrimary and study completion dates: Jun 2023 to Jun 2028Enrollment target: 5112 to 5499 · Study description shortened, about 14 wordsv27Show all 3 changesShow less
NotableTrial status: Active, Not Recruiting to RecruitingEnrollment target: 3834 to 5112 · Primary completion date: Dec 2017 · Completion date: Jun 2008 to Jun 2018 · 4 morev11Show all 8 changesShow less
NotableLead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to University of PennsylvaniaCollaborators revised (7)v10Show all 2 changesShow less
Minor2 versionsRe-verified since Oct 2, 2008, no change to tracked fieldsv8-v9
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 3300 to confirmed 3834 · Completion date: Dec 2009 to Jun 2008 · Site details revised at 13 of 13 sites · 2 morev7Show all 6 changesShow less
Enrollment target: estimated 3300 to confirmed 3834
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic kidney disease (CKD) is a silent epidemic affecting more than 37 million Americans. The burden of morbidity and mortality associated with CKD derives from its frequent progression to end-stage kidney disease (ESKD) and the disproportionate risk of cardiovascular disease (CVD) and associated complications. CKD is strongly and independently associated with CVD, even after adjustment for traditional CVD risk factors. This led to the hypothesis that other risk factors augment the rate of CVD in the setting of CKD. Hence, many patients with progressive renal disease succumb to fatal CVD events before they need renal replacement therapy.
The National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) established the Chronic Renal Insufficiency Cohort (CRIC) Study in 2001 with the initial goal of elucidating the relationship between CKD and CVD. Since its inception, the CRIC Study has recruited and followed a racially and ethnically diverse cohort of over 5,000 participants with reduced kidney function from 13 clinical recruitment sites across the US. The original aim of CRIC was to establish a clinical research laboratory designed to (a) identify novel predictors of CKD progression, and (b) characterize the manifestations of CVD and identify its risk factors among individuals with CKD. The CRIC Study has examined a broad set of etiological factors (clinical, behavioral, and biomarker-associated) potentially responsible for both progressive CKD and CKD-related morbidities, especially those early in the course of CKD. Characterizing relationships between these risk factors and outcomes should facilitate identification of high-risk subgroups with CKD and guide enrollment into preventive treatment trials and application of preventive therapies. Over time, the scientific focus and the CRIC investigator network have broadened extensively through a highly successful ancillary studies program that has included more than 100 projects, most of which have been funded through federal grants. To date, the CRIC Study's investigative activities have resulted in over 300 published scientific papers with many additional manuscripts in development.
Trial Details
NCT Number
NCT00304148
Lead Sponsor
University of Pennsylvania Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Johns Hopkins University, Case Western Reserve University, University of Michigan, University of Illinois at Chicago, Tulane University, Kaiser Permanente